Evaluation of the Efficacy and Safety of a Dual Delayed-Release Formulation of 10-mg Esomeprazole in Patients with Gastric Erosions: A Multicenter, Randomized, Double-Blind, Active-Control, Phase III Study
Abstract
Background/aims: Clinical data on the efficacy and safety of the dual delayed-release formulation of 10-mg esomeprazole (HIP2101) are currently limited. Therefore, this study compared the efficacy and safety of HIP2101 and 20-mg famotidine (RLD2101) in patients with gastric erosions.
Methods: In this multicenter, randomized, double-blind, active-control, phase III study, 326 patients with endoscopically proven gastric mucosal erosion were randomly assigned to receive either HIP2101 or RLD2101 once daily for 2 weeks. The primary endpoint was the rate of improvement of erosion. Secondary endpoints (rate of cure of erosion and edema, and rate of improvement of hematin and gastrointestinal symptoms) and treatment-emergent adverse events were compared between the groups.
Results: Based on the per-protocol set (PPS) analysis, the improvement rates for erosion were 64.9% (98/151) and 63.7% (100/157) in the HIP2101 and RLD2101 groups, respectively (95% confidence interval, -9.5 to 11.9). The lower bound of the 95% confidence interval was greater than the noninferiority margin of -14%. These results were similar to those of the full analysis set (FAS) (HIP2101 group, 64.6%; RLD2101 group, 62.7%). Based on the PPS and FAS analyses, the cure rates for erosion and edema and the improvement rates for hematin and gastrointestinal symptoms were comparable between the groups. The number of adverse events did not differ significantly between the groups.
Conclusions: The efficacy and safety…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 326 participants or records.
Read the paper
Related studies
- Improving sleep quality leads to better mental health: A meta-analysis of randomised controlled trials
- Tocilizumab in patients with severe COVID-19: a retrospective cohort study
- A new aging measure captures morbidity and mortality risk across diverse subpopulations from NHANES IV: A cohort study
- Fruit, vegetable, and legume intake, and cardiovascular disease and deaths in 18 countries (PURE): a prospective cohort study
- Are noise and air pollution related to the incidence of dementia? A cohort study in London, England
- Long COVID symptoms and duration in SARS-CoV-2 positive children — a nationwide cohort study
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.